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ObesityPhase 3NCT07792954

A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity

A Phase 3 study testing Berobenatide in people with Obesity and Overweight, run by Pfizer at 34 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Overweight and obesity are long-term health conditions that can increase the risk of serious health problems, including heart disease, type 2 diabetes, and other medical conditions. The purpose of this study is to learn whether berobenatide is safe and effective for adults in China who have overweight or obesity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight
What is being tested?
Berobenatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
34 sitesChina
Study dates
24 Sep 2026to 23 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults ≥18 years of age.
  • BMI ≥28 kg/m²; or BMI ≥24 kg/m² and <28 kg/m² with at least one weight-related comorbidity.
  • Participants with T2D must have HbA1c 6.5% to 10.0%.
  • At least one prior unsuccessful dietary weight-loss attempt.

Who cannot join

  • Significant recent weight change (>5% within 3 months).
  • Type 1 diabetes mellitus.
  • History of pancreatitis.
  • Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2).
  • Recent bariatric surgery or obesity procedures.
  • Pregnancy or breastfeeding.

Trial locations and contacts

34 sites in 1 country. Contact the study team or a site near you to ask about taking part.

34 sites in 1 country

China34 sites, 34 recruiting
  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Recruiting
  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

    Not yet recruiting
  • Beijing Pinggu Hospital

    Beijing, Beijing Municipality, 101200

    Not yet recruiting
  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

    Not yet recruiting
  • The Second Hospital of Jilin University

    Changchun, Jilin, 130022

    Not yet recruiting
  • Changzhou Second People's Hospital

    Changzhou, Jiangsu, 213164

    Not yet recruiting
  • Chongqing People's Hospital

    Chongqing, Chongqing Municipality, 400013

    Not yet recruiting
  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

    Not yet recruiting
  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

    Not yet recruiting
  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Not yet recruiting
  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230011

    Not yet recruiting
  • Harrison International Peace Hospital

    Hengshui, Hebei, 053000

    Not yet recruiting
  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516001

    Not yet recruiting
  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313000

    Not yet recruiting
  • Jinan Central Hospital

    Jinan, Shandong, 250013

    Not yet recruiting
  • Luoyang First People's Hospital

    Luoyang, Henan, 471000

    Recruiting
  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan, 471023

    Not yet recruiting
  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330038

    Not yet recruiting
  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

    Recruiting
  • Nanjing First Hospital

    Nanjing, Jiangsu, 210012

    Not yet recruiting
  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

    Not yet recruiting
  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang, 315010

    Not yet recruiting
  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

    Not yet recruiting
  • Zhongshan Hospital,Fudan University

    Shanghai, Shanghai Municipality, 200032

    Not yet recruiting
  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

    Not yet recruiting
  • The Fifth People's Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200240

    Not yet recruiting
  • Pudong New Area People's Hospital Shanghai

    Shanghai, Shanghai Municipality, 201299

    Not yet recruiting
  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Not yet recruiting
  • Shiyan Taihe Hospital

    Shiyan, Hubei, 442000

    Not yet recruiting
  • Tianjin Medical University General Hospital

    Tianjin, 300052

    Not yet recruiting
  • Wuhan Third Hospital

    Wuhan, Hubei, 430060

    Not yet recruiting
  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi, 400016

    Not yet recruiting
  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

    Not yet recruiting
  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

    Not yet recruiting

Other trials in China

About this study

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-WEEKLY PF-08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY

Overweight and obesity are long-term health conditions that can increase the risk of serious health problems, including heart disease, type 2 diabetes, and other medical conditions.

The purpose of this study is to learn whether berobenatide is safe and effective for adults in China who have overweight or obesity. Researchers will compare berobenatide with a placebo, which looks like the study treatment but does not contain active medicine.

Read more

People may be able to participate if they are adults with obesity or if they have overweight together with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment.

Participants will be randomly assigned to receive either berobenatide or placebo. The study treatment will be administered according to the study protocol, and participants will be monitored throughout the study to assess changes in body weight and overall health, as well as any side effects that may occur.

During participation, participants will attend study visits and complete study-related assessments. Researchers will collect information about participants' health, body weight, and safety throughout the study. Details about the number of visits, study duration, and study procedures will be explained by the study team before participation.

The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.

Conditions
Obesity, Overweight
Being tested
Berobenatide, Placebo
Keywords
Obesity, Overweight, Weight Management, Weight Reduction, Body Weight, Chronic Weight Management, Adults With Obesity, Adults With Overweight
Medical subject headings
Obesity, Overweight, Weight Loss, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BerobenatideDrug

    Also called PF-08653944

    Solution for injection

  • PlaceboOther

    Solution for injection

Study groups in NCT07792954
Study groupRoleWhat they receive
Berobenatide Medium Maintenance DoseExperimentalParticipants will receive Berobenatide once weekly during a dose-escalation phase followed by a medium maintenance dose during the maintenance phase.
Receives: Drug: Berobenatide
Placebo Matched to Low-Dose BerobenatidePlacebo comparatorParticipants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Receives: Other: Placebo
Berobenatide Low Maintenance DoseExperimentalParticipants will receive Berobenatide once weekly during a dose-escalation phase followed by a low maintenance dose during the maintenance phase.
Receives: Drug: Berobenatide
Berobenatide High Maintenance DoseExperimentalParticipants will receive Berobenatide once weekly during a dose-escalation phase followed by a high maintenance dose during the maintenance phase.
Receives: Drug: Berobenatide
Placebo Matched to Medium-Dose BerobenatidePlacebo comparatorParticipants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Receives: Other: Placebo
Placebo Matched to High-Dose BerobenatidePlacebo comparatorParticipants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Body Weight at Week 48

    Measured: Baseline to Week 48

Secondary outcomes (32)
  1. Change From Baseline in Body Weight at Week 48

    Measured: Baseline to Week 48

  2. Percentage of Participants achieving ≥5% of body weight reduction from baseline

    Measured: Baseline, Week 48

  3. Percentage of Participants achieving ≥10% of body weight reduction from baseline

    Measured: Baseline, Week 48

  4. Percentage of Participants achieving ≥15% of body weight reduction from baseline

    Measured: Baseline, Week 48

  5. Percentage of Participants achieving ≥20% of body weight reduction from baseline

    Measured: Baseline, Week 48

  6. Change from baseline in waist circumference

    Measured: Baseline, Week 48

  7. Change from baseline in Non-High-density lipoprotein cholesterol

    Measured: Baseline, Week 48

  8. Change from baseline in Fasting triglycerides

    Measured: Baseline, Week 48

  9. Change from baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 48

  10. Change from baseline in Short Form 36 health survey (SF-36) Physical Function domain score

    Measured: Baseline, Week 48

  11. Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score

    Measured: Baseline, Week 48

  12. Change from baseline in Diastolic Blood Pressure (DBP)

    Measured: Baseline, Week 48

  13. Change from baseline in Fasting Total Cholesterol

    Measured: Baseline, Week 48

  14. Change from baseline in Low-density lipoprotein cholesterol

    Measured: Baseline, Week 48

  15. Change from baseline in Very low-density lipoprotein cholesterol

    Measured: Baseline, Week 48

  16. Change from baseline in High-density lipoprotein cholesterol

    Measured: Baseline, Week 48

  17. Change from Baseline in HbA1c

    Measured: Baseline, Week 48

  18. Change from baseline in Fasting Plasma Glucose

    Measured: Baseline, Week 48

  19. Change from baseline in Fasting Insulin

    Measured: Baseline, Week 48

  20. Change from baseline in hs-CRP (high-sensitivity C-reactive protein)

    Measured: Baseline, Week 48

  21. Change from baseline in Interleukin-6 (IL-6)

    Measured: Baseline, Week 48

  22. Change from baseline in IWQoL-Lite-CT Physical Composite

    Measured: Baseline, Week 48

  23. Change from baseline in IWQoL-Lite-CT Psychosocial Composite

    Measured: Baseline, Week 48

  24. Change from baseline in SF-36 domain scales and component summary scales

    Measured: Baseline, Week 48

  25. Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score

    Measured: Baseline, Week 48

  26. Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)

    Measured: Baseline, Week 48

  27. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to Week 58

  28. Number of participants with Serious Adverse Events (SAE)

    Measured: Up to Week 58

  29. Number of participants with AE leading to permanent discontinuation from study intervention or study

    Measured: Up to Week 58

  30. Percentage of participants with T2D at screening achieving HbA1c <7.0%

    Measured: Up to Week 48

  31. Percentage of participants with Type 2 diabetes (T2D) at screening achieving HbA1c <5.7%

    Measured: Up to Week 48

  32. Change from Baseline in Body mass index (BMI)

    Measured: Baseline, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start24 Sep 2026
  3. Primary completion14 Mar 2028 (estimated)
  4. Study completion23 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07792954
Sponsor's protocol ID
C6491018
Status last verified
Oct 2026
First submitted
25 Aug 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Berobenatide in people with Obesity and Overweight, run by Pfizer at 34 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight at Week 48 (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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Clinical Trial NCT07792954 | AzTrials